Safety concerns over imported counterfeit melatonin products

The Therapeutic Goods Administration (TGA) is issuing an updated safety advisory regarding imported counterfeit unregistered melatonin products.

Test results

Laboratory testing of several imported unregistered melatonin products has confirmed they are counterfeit under the Therapeutic Goods Act 1989.

The results indicate significant discrepancies in the actual melatonin content compared to the labelled amounts. One product contained more than 400% of the labelled content and another containing no melatonin at all. See the summary report for information on all the samples tested.

This variability in melatonin content raises serious safety concerns for consumers, including the risk of accidental overdose and hospitalisation, especially in children.

The following products contained significantly more than the labelled amount:

The following products contained significantly less than the labelled amount:

Why choose regulated medicines

The products tested by TGA Laboratories are known as unregistered therapeutic goods. These products can often be purchased online or from local retailers, however, they may not meet Australian standards for safety, quality and effectiveness.

To check if a product is on the Australian Register of Therapeutic Goods (ARTG), look for an AUST R or AUST L number on the packaging. This number confirms that the medicine meets Australian standards, including:

• the ingredients listed on the label are accurate
• the product was manufactured under strict safety and quality standards.

Learn more about the Regulation of melatonin products in Australia.

Information for consumers

• Melatonin is a prescription-only medicine in Australia, except in specific circumstances for adults.
• Parents are strongly encouraged to consult their child’s treating medical practitioner regarding the use of melatonin, especially for children with seizure disorders as it may increase seizure frequency.
• Melatonin products taken without appropriate medical oversight can cause serious side effects including accidental overdose and hospitalisation, especially in children.
• Even with a valid prescription, counterfeit products cannot be imported into Australia under the Personal Importation Scheme.
• Importing, supplying and/or giving away counterfeit therapeutic goods is illegal and poses a significant public health and safety risk.
• Stop using unregistered melatonin products immediately and take any remaining items to your local pharmacy for safe disposal.
• If you have any concerns arising from the use of these or similar products, seek advice from your treating medical practitioner.
• If you suspect you or someone you care for has had a side effect (also known as an adverse event) to this or a similar medicine, report it to the TGA.
• If you are considering purchasing medicines from overseas watch this short video on the risks associated with buying medicines and medical devices online.

We advise consumers to exercise extreme caution when purchasing medicines from unknown overseas websites.

Products purchased over the internet:

• may be fake
• may contain incorrect or undisclosed and harmful ingredients.
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

For your safety, always buy medicines from reputable sources, check for an AUST R or AUST L number, and consult your healthcare provider or local registered pharmacy if you have any questions.

Information for health professionals

Doctors may choose to prescribe melatonin to their patients ‘off-label’. 'Off-label use' is a clinical decision made at the discretion of the treating clinician who is responsible for obtaining informed consent from their patient and ensuring that the medicine is the appropriate treatment option and carries a positive benefit–risk profile.

The TGA does not regulate clinical practice or off-label use.

Health professionals also play a key role in identifying and managing the risks associated with unregistered melatonin products and should advise patients accordingly.

Health professionals are encouraged to report adverse events involving medicines, including unapproved medicines. These reports assist the TGA in identifying previously unknown side effects and other safety issues.

Action we are taking

The TGA continues to monitor signals relating to harmful unregistered products and will notify the Australian Border Force (ABF) to seize and destroy any counterfeit products intercepted at the border.

Reporting problems

If you experience an adverse event you are encouraged to report it to the TGA as this helps us monitor and respond to emerging safety concerns.

If you suspect non-compliance in relation to therapeutic goods, you can report a perceived breach or questionable practice online to the TGA.

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